Amendments to the registration certificate
Grounds for making changes to the registration certificate:
A. Change in information about the applicant, including information: on the reorganization of a legal entity; about changing its name (full and (if any) abbreviated, including company name), address (location); on changing the last name, first name and (if any) patronymic, address of the place of residence of an individual entrepreneur, details of an identity document;

B. Change of address (place of production) of a medical product;

C. Change in the name of the medical device (in case the properties and characteristics that affect the quality, efficiency and safety of the medical device have not changed);

D. Change in information about the legal entity in whose name a registration certificate may be issued, including information on: reorganization of the legal entity; about changing its name (full and (if any) abbreviated, including company name), address (location);

E. Indication of the type of medical device in accordance with the nomenclature classification of medical devices (in case of its absence).

Changes to the certificate:

The amount of the state duty:
The state duty for making changes to the registration certificate is 2 500 rubles.
Cost calculation:
List of information required to calculate the cost of registering a medical device:
  • Name of the medical device;
  • Purpose and scope;
  • Specifications;
  • The materials from which the medical device is made;
  • Analogues registered in the Russian Federation.
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